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DABIGATRAN ETEXILATE ACCORD is a brand name for Dabigatran Etexilate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension. Treatment of deep vein thrombosis (DVT)…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Dabigatran etexilate Accord hard capsules can be used in adults and paediatric patients aged 8 years or older who are able to swallow the capsules whole. Other pharmaceutical forms may be more appropriate for administration to this population such as coated granules which can be used in children aged less than 12 years as soon as the child is able to swallow soft food.
When changing between the formulations, the prescribed dose may need to be altered. The dose stated in the relevant dosing table of a formulation should be prescribed based on the weight and age of the child. Prevention of stroke and systemic embolism in adult patients with NVAF with one or more risk factors (SPAF) Treatment of DVT and PE, and prevention of recurrent DVT, and PE in adults (DVT/PE) The recommended doses of dabigatran etexilate in the indications SPAF, DVT and PE are shown in table 1.
Table 1:
Dose recommendations for SPAF, DVT and PE Dose recommendation Prevention of stroke and systemic embolism in adult patients with NVAF with one or more risk factors (SPAF) 300 mg dabigatran etexilate taken as one 150 mg capsule twice daily Treatment of DVT and PE, and prevention of recurrent DVT, and PE in adults (DVT/PE) 300 mg dabigatran etexilate taken as one 150 mg capsule twice daily following treatment with a parenteral anticoagulant for at least 5 days Dose reduction recommended Patients aged ≥ 80 years Patients who receive concomitant verapamil daily dose of 220 mg dabigatran etexilate taken as one 110 mg capsule twice daily Dose reduction for consideration Patients between 75-80 years Patients with moderate renal impairment (CrCL 30-50 mL/min) Patients with gastritis, oesophagitis or gastroesophageal reflux Other patients at increased risk of bleeding daily dose of dabigatran etexilate of 300 mg or 220 mg should be selected based on an individual assessment of the thromboembolic risk and the risk of bleeding For DVT/PE the recommendation for the use of 220 mg dabigatran etexilate taken as one 110 mg capsule twice daily is based on pharmacokinetic and pharmacodynamic analyses and has not been studied in this clinical setting.
2. In case of intolerability to dabigatran etexilate, patients should be instructed to immediately consult their treating physician in order to be switched to alternate acceptable treatment options for prevention of stroke and systemic embolism associated with atrial fibrillation or for DVT/PE.
Summary of the safety profile Dabigatran etexilate has been evaluated in clinical trials overall in approximately 64000 patients; thereof approximately 35000 patients were treated with dabigatran etexilate. In total, 22% of patients with atrial fibrillation treated for the prevention of stroke and systemic embolism (long-term treatment for up to 3 years), 14% of patients treated for DVT/PE and 15% of patients treated for DVT/PE prevention experienced adverse reactions.
4% of adult patients treated for DVT/PE. 5% of patients in the DVT/PE prevention trial RE-SONATE (adult patients). Since the patient populations treated in the three indications are not comparable and bleeding events are distributed over several System Organ Classes (SOC), a summary description of major and any bleeding are broken down by indication and are provided in tables 12- 15 below.
Although low in frequency in clinical trials, major or severe bleeding may occur and, regardless of location, may lead to disabling, life-threatening or even fatal outcomes. Tabulated list of adverse reactions Table 11 shows the adverse reactions identified studies and post-marketing data in the indications prevention of thromboembolic stroke and systemic embolism in patients with atrial fibrillation, DVT/PE treatment and DVT/PE prevention.
They are ranked under headings of System Organ Class (SOC) and frequency using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (1/1000 to < 1/100), rare (≥ 1/10000 to < 1/1000), very rare (< 1/10000) and not known (cannot be estimated from the available data).
Table 11:
Adverse reactions Frequency SOC / Preferred term Stroke and systemic embolism prevention in patients with atrial fibrillation DVT/PE treatment and DVT/PE prevention Blood and lymphatic system disorders Anaemia Common Uncommon Haemoglobin decreased Uncommon Not known Thrombocytopenia Uncommon Rare Haematocrit decreased Rare Not known Neutropenia Not known Not known Agranulocytosis Not known Not known Immune system disorder Drug hypersensitivity Uncommon Uncommon Rash Uncommon Uncommon Pruritus Uncommon Uncommon Anaphylactic reaction Rare Rare Angioedema Rare Rare Urticaria Rare Rare Bronchospasm Not known Not known Nervous system disorders Intracranial haemorrhage Uncommon Rare Vascular disorders Haematoma Uncommon Uncommon Haemorrhage Uncommon Uncommon Respiratory, thoracic and mediastinal disorders Epistaxis Common Common Haemoptysis Uncommon Uncommon Gastrointestinal disorders Gastrointestinal haemorrhage Common Common Abdominal pain Common Uncommon Diarrhoea Common Uncommon Dyspepsia Common Common Nausea Common Uncommon Rectal haemorrhage Uncommon Common Haemorrhoidal haemorrhage Uncommon Uncommon Gastrointestinal ulcer, including oesophageal ulcer Uncommon Uncommon Gastroesophagitis Uncommon Uncommon Gastroesophageal reflux disease Uncommon Uncommon Vomiting Uncommon Uncommon Dysphagia Uncommon Rare Hepatobiliary disorders Hepatic function abnormal / Liver function Test abnormal Uncommon Uncommon Alanine aminotransferase increased Uncommon Uncommon Aspartate aminotransferase increased Uncommon Uncommon Hepatic enzyme increased Rare Uncommon Hyperbilirubinaemia Rare Not known Skin and subcutaneous tissue disorder Skin haemorrhage Common Common Alopecia Not known Not known Musculoskeletal and connective tissue disorders Haemarthrosis Rare Uncommon Renal and urinary disorders Genitourological haemorrhage, including haematuria Common Common General disorders and administration site conditions Injection site haemorrhage Rare Rare Catheter site haemorrhage Rare Rare Injury, poisoning and procedural complications Traumatic haemorrhage Rare Uncommon Incision site haemorrhage Rare Rare Description of selected adverse reactions Bleeding reactions Due to the pharmacological mode of action, the use of dabigatran etexilate may be associated with an increased risk of occult or overt bleeding from any tissue or organ.
Haemorrhagic risk Dabigatran etexilate should be used with caution in conditions with an increased risk of bleeding or with concomitant use of medicinal products affecting haemostasis by inhibition of platelet aggregation. Bleeding can occur at any site during therapy.
An unexplained fall in haemoglobin and/or haematocrit or blood pressure should lead to a search for a bleeding site. For adult patients in situations of life-threatening or uncontrolled bleeding, when rapid reversal of the anticoagulation effect of dabigatran is required, the specific reversal agent idarucizumab is available.
The efficacy and safety of idarucizumab have not been established in paediatric patients. Haemodialysis can remove dabigatran. 9). In clinical trials, dabigatran etexilate was associated with higher rates of major gastrointestinal (GI) bleeding.
An increased risk was seen in the elderly (≥ 75 years) for the 150 mg twice daily dose regimen. Further risk factors (see also table 4) comprise co- medication with platelet aggregation inhibitors such as clopidogrel and acetylsalicylic acid (ASA) or non steroidal antiinflammatory drugs (NSAID), as well as the presence of oesophagitis, gastritis or gastroesophageal reflux.
Risk factors Table 4 summarises factors which may increase the haemorrhagic risk.
Table 4:
Factors which may increase the haemorrhagic risk. g. 2). 5). 9. 5), which significantly increase the risk of major bleeding requires a careful benefit-risk assessment. Dabigatran etexilate should only be given if the benefit outweighs bleeding risks.
1). In these patients, dabigatran etexilate should only be given if the expected benefit outweighs bleeding risks. Close clinical surveillance Close observation for signs of bleeding or anaemia is recommended throughout the treatment period, especially if risk factors are combined (see table 4 above).
73 m2 in paediatric patients • Active clinically significant bleeding • Lesion or condition, if considered a significant risk factor for major bleeding. g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin etc), heparin derivatives (fondaparinux etc), oral anticoagulants (warfarin, rivaroxaban, apixaban etc) except under specific circumstances.
1).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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e. 2). g. hypovolaemia, dehydration, and in case of concomitant use of certain medicinal products). g. hypovolaemia, dehydration, and in case of concomitant use of certain medicinal products). The method to be used to estimate renal function (CrCL in mL/min) is the Cockcroft-Gault method.
Duration of use The duration of use of dabigatran etexilate in the indications SPAF, DVT and PE are shown in table 2.
Table 2:
Duration of use for SPAF and DVT/PE Indication Duration of use SPAF Therapy should be continued long term. 4). g. recent surgery, trauma, immobilisation) and longer durations should be based on permanent risk factors or idiopathic DVT or PE.
Missed dose A forgotten dabigatran etexilate dose may still be taken up to 6 hours prior to the next scheduled dose. From 6 hours prior to the next scheduled dose on, the missed dose should be omitted. No double dose should be taken to make up for missed individual doses.
Discontinuation of dabigatran etexilate Dabigatran etexilate treatment should not be discontinued without medical advice. 8). 5). g. 5).
Dabigatran etexilate treatment to Vitamin K antagonists (VKA):
The starting time of the VKA should be adjusted based on CrCL as follows: • CrCL ≥ 50 mL/min, VKA should be started 3 days before discontinuing dabigatran etexilate • CrCL ≥ 30-< 50 mL/min, VKA should be started 2 days before discontinuing dabigatran etexilate Because dabigatran etexilate can impact the International Normalised Ratio (INR), the INR will better reflect VKA’s effect only after dabigatran etexilate has been stopped for at least 2 days.
Until then, INR values should be interpreted with caution. VKA to dabigatran […]
The signs, symptoms, and severity (including fatal outcome) will vary according to the location and degree or extent of the bleeding and/or anaemia. g. gastrointestinal, genitourinary) were seen more frequently during long term dabigatran etexilate treatment compared with VKA treatment.
Thus, in addition to adequate clinical surveillance, laboratory testing of haemoglobin/haematocrit is of value to detect occult bleeding. g. 4 Haemorrhagic risk). Haemorrhagic complications may present as weakness, paleness, dizziness, headache or unexplained swelling, dyspnoea, and unexplained shock.
Known bleeding complications such as compartment syndrome and acute renal failure due to hypoperfusion and anticoagulant-related nephropathy in patients with predisposing risk factors have been reported for dabigatran etexilate. Therefore, the possibility of haemorrhage is to be considered in evaluating the condition in any anticoagulated patient.
9). Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors (SPAF) Table 12 shows bleeding events broken down to major and any bleeding in the pivotal study testing the prevention of thromboembolic stroke and systemic embolism in patients with atrial fibrillation.
Table 12:
Bleeding events in a study testing […]
5). 5). 3). When severe bleedings occur, treatment must be discontinued, the source of bleeding investigated and use of the specific reversal agent (idarucizumab) may be considered in adult patients. The efficacy and safety of idarucizumab have not been established in paediatric patients.
Haemodialysis can remove dabigatran. Use of proton-pump inhibitors The administration of a proton-pump inhibitor (PPI) can be considered to prevent GI bleeding. In case of paediatric patients local labeling recommendations for proton pump inhibitors have to be followed.
Laboratory coagulation parameters Although this medicinal product does not in general require routine anticoagulant monitoring, the measurement of dabigatran related anticoagulation may be helpful to detect excessive high exposure to dabigatran in the presence of additional risk factors.
1). The international normalised ratio (INR) test is unreliable in patients on dabigatran etexilate and false positive INR elevations have been reported. Therefore INR tests should not be performed. Table 5 shows coagulation test thresholds at trough for adult patients that may be associated with an increased risk of bleeding.
1) Table 5: Coagulation test thresholds at trough for adult patients that may be associated with an increased risk of bleeding. Test (trough value) Indication SPAF and DVT/PE dTT [ng/mL] > 200 ECT [x-fold upper limit of normal] > 3 aPTT [x-fold upper limit of normal] > 2 INR Should not be performed Use of fibrinolytic medicinal products for the treatment […]